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Clinical Trials in Germany / NCT06533163
Recruiting Not applicable

Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial

NCT06533163 · tracked via the Priya Life Science Germany tracker
Sponsor
BioTex, Inc
Phase
Not applicable
Started
2025-02-17
Last updated
2026-06-02

Condition(s) studied

Glioblastoma Multiforme

Investigational drug(s) / intervention(s)

Oncomagnetic device

Oncomagnetic device: OncoMAGNETX has developed a portable wearable noninvasive magnetic device (Oncomagnetic device) for the treatment of GBM.

Study summary

The clinical investigation is a non-randomized, multicenter, open-label, prospective, exposure-time escalation clinical investigation. The clinical investigation is designed to assess the clinical safety and performance of the Oncomagnetic Device.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. The subject is at least 18 years of age. 2. The subject previously had maximal safe resection (MSR) for glioblastoma (GBM) per the discretion of the investigator and is able to receive standard radiotherapy (unless contraindicated or refused by the subject) 3. The subject has a newly confirmed diagnosis of GBM per WHO classification criteria. 4. The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review. 5. The subject has a confirmed unmethylated MGMT promoter status. 6. The subject has a KPS ≥ 70. 7. The subject's life expectancy is \>12 weeks. 8. The subject is no longer taking corticosteroids. 9. The subject has signed and dated the consent form. 10. The subject has stated understanding and willingness to comply with all clinical investigation procedures and availability for the duration of the clinical investigation. Exclusion Criteria: 1. The subject has a tumor in the brainstem, extensive or multicentric disease (e.g. in both hemispheres), or an abnormal regrowth pattern between the post operation MRI and RX planning MRI, suggesting early tumor progression, as determined by the Investigator's discretion. 2. The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in another clinical investigation. 3. The subject has a severe acute infection, any autoimmune disease, significant congenital anomaly, other co-morbidity, or medical problem or is taking immunosuppressant therapy (except Dexamethasone) within 90 days of anticipated device use for a condition that in the opinion of the Investigator and Sponsor precludes enrollment in the investigation. 4. The subject has had a known focal or generalized seizure after surgery. 5. The subject has implants or any condition preventing the patient from undergoing serial MRI scans. 6. The patient has a skull defect (such as, missing bone with no replacement), bullet fragments or ferrous metals. 7. The subject has an active implanted device (e.g., cardiac pacemakers, Vagus Nerve Stimulation \[VNS\], Deep Brain Stimulation \[DBS\], programmable shunts, etc.). 8. The subject has any of the following lab results: * ANC \< 1500 cells/mm3 or \< 1.5 x 10\^9 /L. * Platelet count \< 100,000 cells/mm3. 9. The subject has a history of any previous anti-tumor treatment for a brain tumor. 10. The subject is currently being treated or has been treated with other investigational agents/devices that may compromise the results of this investigation (as per discretion of the Investigator). 11. The subject takes any nutritional supplements or alternative medical treatments that may compromise the results of this investigation (this is as per discretion of the Investigator, but any compound with anti-oxidant properties is strongly discouraged). 12. The subject has planned concomitant or adjuvant chemotherapy.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Clinical Center Stuttgart Stuttgart Baden-Wurttemberg Recruiting
Technical University of Munich München Bavaria Recruiting
University Hospital Bonn Bonn North Rhine-Westphalia Recruiting
Clinical Center Lünen Lünen North Rhine-Westphalia Recruiting
University Hospital Leipzig Leipzig Saxony Recruiting
Medical Center Mannheim Mannheim Germany Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06533163 on ClinicalTrials.gov ↗ ← All trials in Germany